FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
ENDOCRINOLOGIC AND METABOLIC DRUGS
ADVISORY COMMITTEE MEETING
QUESTIONS TO THE COMMITTEE
sNDA 19-640/S-033, HumatropeŽ (somatropin [rDNA origin] for injection),
Eli Lilly and Company. Proposed for the indication of non-growth hormone deficient short stature (NGHDSS).
1. Has the efficacy of Humatrope in NGHDSS been sufficiently characterized?
2. Has the safety of Humatrope in NGHDSS been sufficiently characterized?
3. Are the available data from the studies presented sufficient to guide the safe and effective use of Humatrope in patients with NGHDSS?
i. the need for information on effect of individualization of dose, age at initiation of therapy, and duration of therapy on growth response and on safety
ii. the need for information on potentially useful predictors of response, both pre-treatment and on-treatment (e.g., early growth or biomarker effects), again to enhance safe and effective use
4. Please comment on the sponsors risk management proposals?
5. Please comment on additional concerns regarding safety and efficacy.
6. Do you recommend that the use of GH in NGHDSS as proposed by the sponsor be approved by FDA?